103.5 Organization Policy on Meeting Procedures

April 2016

The Organization confers the responsibility for establishing JHM IRB meeting procedures to the Vice Dean for Clinical Investigation (the Institutional Official), the OHSR Director of Operations and OHSR Assistant Dean for Human Subjects Compliance, and the Chairs of the JHM IRBs. These procedures include limitations on the number of applications to be discussed at convened meetings, preparing the agendas for the meetings, assembling and distributing the meeting packets, selecting the primary reviewer, recording and processing the minutes of the meeting, and communicating with investigators. Convened meetings for all JHM IRBs, except for JHM ACH IRB, shall occur weekly, unless circumstances dictate a meeting must be cancelled (examples: lack of quorum, University holidays, weather related changes, etc.) JHM ACH IRB meetings will occur monthly.

If it is determined in advance of a JHM IRB meeting that a quorum of members will not be available, the meeting will be canceled. If a quorum is present at the beginning of the meeting but is lost during the meeting, no further actions will be taken and the agenda items that had not been voted on will be transferred to the next available meeting, and the loss of quorum will be documented in the minutes. The JHM IRB Chair and Regulatory Affairs Specialists will jointly determine whether a quorum is present.

The IRB Chair (or Co-Chair, when chairing a meeting), is expected to (i) review all convened agenda items prior to the meeting to provide oversight and facilitate comprehensive discussion and deliberation, (ii) lead the meeting as further described in JHM IRB Policy 108.1, and (iii) summarize the issues to be forwarded to the PI for response when a study is approved with administrative changes or tabled, and (iv) summarize the reasons for disapproval when a study is disapproved.

The JHM IRB meeting will begin when a quorum is present, including a non-scientific member. The Chair or Co-Chair will open the meeting and call each application or item of business before the committee. In the event that the Chair is called from the room or leaves early, the Co-Chair may continue the meeting. If both the Chair and the Co-Chair are out of the room, the meeting may continue so long as a quorum exists and the Chair or Co-Chair appoint a member to conduct the meeting.